Non-Chemotherapy Combo Approved for Treatment-Naïve CLL/SLL Patients

The U.S. Food and Drug Administration (FDA) has approved IMBRUVICA® (ibrutinib) in combination with Gazyva (obinutuzumab) for treatments of patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). 1

The FDA approval was based on results from the Phase 3 iLLUMINATE clinical trial which compared Gazyva administered with either Imbruvica or chlorambucil in 212 adult patients. The overall response rate was 89% in the Imbruvica treated patients compared to only 73% in the chlorambucil group. Treatment with Imbruvica + Gazyva also led to a significant delay in cancer progression. Chlorambucil treated patients survived an average of 19 months without cancer Imbruvica treated patients’ experienced a 77 percent reduction in the risk of cancer progression or death compared to those treated with chlorambucil.

Imbruvica as a single agent – and now as a combination with Gazyva – provides patients with CLL with an alternative to frontline treatment with chemoimmunotherapy.